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Efficacy and Safety of Very Early Mobilisation within 24 Hours of Stroke Onset (AVERT): A Randomised Controlled Trial

Shayne Kreutzer, Mercer University College of Pharmacy

According to the American Heart Association/American Stroke Association (AHA/ASA), a stroke is a disease that affects the arteries leading to and within the brain. It is suggested that this is the fifth leading cause of death and a leading cause of disability in the United States. It further stated that a stroke occurs when a blood vessel carrying oxygen and nutrients to the brain is either blocker by a clot or bursts. When this occurs, it is suggested that stroke is a disease that affects the arteries leading to and within the brain.1
According to Guidelines for the Primary Prevention of Stroke, stroke is the leading cause of functional impairment. It stated that patients 65 years of age and older, 6 months after a stroke, 26% are dependent in their activities of daily living, and 46% have cognitive deficits.2

According to the 2015 AHA/ASA Focused update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment, the use of rapid administration of intravenous (IV) recombinant tissue-type plasminoten activator (r-tPA) to appropriate patients remains the mainstay of early treatment of acute ischemic stroke. It is suggested that timely restoration of blood flow in ischemic stroke patients is effective in reducing long term morbidity. According to the guidelines, patients who meet national and international eligibility guidelines, IV r-tPA administration improves functional outcomes at 3 to 6 months when given within 4.5 hours of ischemic stroke onset and should be administered.3

Title: Efficacy and Safety of Very Early Mobilisation within 24 Hours of Stroke Onset (AVERT): A Randomised Controlled Trial4

Patients were randomly assigned, 1:1, with a secure remote, web-based computer generated block randomisation procedure to receive usual stroke-unit care along or very early mobilisation in addition to usual care. Components of usual care were at the discretion of the site. Very early mobilisation included three crucial elements: 1. Begin within 24 hours of stroke onset; 2. Focus on sitting, standing, and walking activity; 3. Result in at least three additional out-of-bed sessions to usual care.

Duration

July 18, 2006 – October 16, 2014

Primary Outcome Measure

Modified Rankin Scale at 3 months

Baseline Characteristics

Very early mobilisation

Usual care

Age (years)

72.3

72.7

Male sex

61%

61%

Premorrbid modified Rankin Scale (mRS)

0

76%

75%

1

14%

15%

2

10%

10%

Time to randomization (hours)

18.2

18.2

First stroke

83%

80%

Results

mRS score

Very early mobilisation

Usual care

0

9%

9%

1

19%

19%

2

28%

22%

3

23%

21%

4

14%

12%

5

9%

10%

6

8%

7%

Adverse Events

Common Adverse Events: Stroke progression (6%)

Serious Adverse Events:

Very early mobilisation

Usual care

Non-fatal

1

15%

1

14%

2

3%

2

4%

3

1%

3

2%

4

< 1%

4

< 1%

5

0%

5

< 1%

Immobility

1

5%

1

4%

2

< 1%

2

1%

3

0%

3

< 1%

Neurological

1

10%

1

7%

2

< 1%

2

< 1%

3

0%

3

< 1%

Percentage that Discontinued due to Adverse Events: 0%

Study Author Conclusions

Our very early mobilisation protocol was effectively delivered, leading to an earlier, more frequent, and higher dose of out-of-bed sitting, standing, and walking activity than usual care. The very early mobilisation intervention significantly reduced the odds of a favourable outcome 3 months after stroke compared with lower dose usual care starting.

The use of r-tPA is a critical factor in the prevention of worsening stroke and ultimately death. The use of r-tPA allows for the brain blood flow to be restored and prevention of brain cell death. This trial showed that there was a benefit of very early ambulation in the fact that the study patients had lower mRS score, meaning less or no disability. Although the study had many limitations, like variable usual care per study location, this study still proves that early ambulation could be used in the treatment of stroke.